Answer: Under federal law, an IRB is a group of scientific and non-scientific individuals who review research studies that involve human subjects. The IRB may approve, require changes in or disapprove the research to fulfill its responsibility to help protect the rights and welfare of human subjects. The IRB reviews the research to make sure it is well designed, that the risks are as low as possible, and that these risks are reasonable when compared to the possible benefits of the research. If the IRB approves the research, the IRB continues to review the ongoing research after it starts. It is important to understand that IRB approval does not mean that a research project is safe or that it is right for you. When an IRB approves research, it means that the members of the IRB believe that the research is acceptable to present to people like you for your consideration. However, you need to carefully look at the details of the research and decide whether it is right for you.

Question: What is the FDA?

Answer: The Food and Drug Administration or "FDA" is an agency of the United States government charged with, among other things, the oversight of the development of investigational drugs and medical devices.

Question: What is a clinical trial?

Answer: A clinical trial is a research study involving human subjects designed to answer specific questions. The question varies from study to study. The research protocol clearly states the question to be asked and discusses all of the tests and procedures that will be done during the research study. The U.S. government requires that, before a drug or a device can be sold in the U.S., it must be studied in research and the results must show that it is relatively safe and effective for its intended use in humans. If you decide to enter a research study, be sure you know what question the research is trying to answer.

Clinical trials are conducted according to a plan called a protocol. The protocol describes what types of subjects may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as the outcomes that will be measured. Doctors and other health professionals conduct the studies according to federal, state, and local laws designed to protect people involved in research.

Answer: The sponsor pays for the research to be done. All research has a sponsor. The sponsor may be a government agency like the National Institutes of Health (NIH), a pharmaceutical or device company, a public institution like a University or Medical College, or an individual person.

Question: What is a protocol?

Answer: The protocol is the "blueprint" for how the study will be conducted. All the details of the study are described in the protocol. The principal investigator and other research staff must follow the protocol. If the protocol is not followed, the results of the research study may not be useful enough to answer the questions the research is trying to answer.

Question: What is a Principal Investigator or PI?

Answer: The principal investigator (PI) is the person responsible for conducting a research project at one or more locations. The PI is usually a medical doctor. Your own physician may be the PI for a research study or the principal investigator could be a physician who only conducts research studies.

PI’s often have other professionals assisting with the research study. The PI’s research team may include sub-investigators, research coordinators and research nurses. Even if there are other doctors on the research team, the PI is the person ultimately responsible for ensuring that the research is being done according to the protocol.

Question: What is a research subject?

Answer: A research subject may be either a healthy individual or a patient who is taking part in a research study.

Question: Who protects a research subject?

Answer: The subject has an obligation to learn about the research study they are considering, ask questions of the investigator, and weigh the risk and benefits prior to independently making a choice of whether to take part.

Investigators (PI’s), sponsors, ethical review boards or IRBs, and regulatory agencies (such as the Food & Drug Administration and Office for Human Research Protections) also help protect the subject. Each group plays a unique role in the protection of subjects, but by working together, they can accomplish what no single group can do alone.

IRB - This group review serves an important role in the protection of the rights and welfare of human research subjects. The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials (e.g. subject information and consent forms and investigator brochures) to ensure protection of the rights and welfare of human subjects of research.

PI- The PI responsible for ensuring that the research study is conducted according to the protocol and in compliance with applicable regulations, for assuring that human subjects are protected, and for controlling any investigational product being used during the study.

The ultimate goal is to afford the best possible protection of any subject who volunteers to take part in a research study.

Question: Why would I be considered a subject/participant and not a patient?

Answer: The requirement in research to follow a protocol is what makes a research study different from the medical care patients receive from their personal doctor. When people are in research studies they are subjects. When people see their regular doctor for medical care, they are patients. For a patient, the treating doctor uses his or her clinical judgment to do what is best for each patient. A patient may be started on one course of treatment, then switched to another treatment if the doctor determines that the patient is not improving, or is experiencing side effects. What a doctor does for his or her patient depends on what will be best for the patient.

On the other hand, when a person participates in a research study as a subject, the PI must follow the study protocol and provide only the medical care that is specified in the protocol. Consequently the tests and medicines given to the subject may be different than the doctor would give to his or her patient. There are several things commonly done in research studies that are not done in regular medical care, such as randomization, blinding, and use of placebo. It is important to know and remember that there is a difference between being a patient and being a research subject.

Question: What is informed consent?

Answer: Federal law requires that people considering taking part in a research study must be given sufficient information about the study before they agree to participate. This is known as the informed consent process. If the individual agrees to participate, he/she must sign an informed consent document, which states:

That the study involves research;

The purpose of the research (why is the study being done);

How long the study is expected to last;

What the study involves and which parts are experimental (not standard of care);

Possible risks and/or discomforts;

Possible benefits;

Will there be compensation for participating;

Alternative treatments available for your condition;

That the study records will be kept confidential to the extent required by law;

What will happen in the event of an injury/side-effect, including whether any compensation and/or medical treatments are available;

Whom to contact with any complaints about the study, questions about research subjects' rights, and questions about injuries related to the research; and

Who will receive information about you from the study;

That being in the study is completely voluntary and subjects may quit at any time.

Answer: Before signing the informed consent document, the subject should discuss the study in detail with the PI or a study staff member. This discussion must take place in private, and the subject must be given enough time to make a decision. In most studies the subject should be allowed to take the consent document home for further discussion with others such as family and primary care physicians. In addition, the study doctor and/or staff must answer all questions to the subject's satisfaction.

Examples of questions to ask may include:

Why is the study being done?

How much of my time will be required?

Will I be paid for being in the study?

Sometimes subjects are paid to participate in a research study. For studies involving individuals with medical problems, the amount of payment is usually based on how inconvenient it is for subjects to come in for the extra visits and to have additional procedures performed. Therefore, the payment will often cover costs like parking and babysitting. Research studies for healthy people generally pay more, as these subjects have no medical problem and may have little other reason to join the study.

Has anyone in this study been injured by the study drug or device?

What side effects/risk may occur with the study drug or device?

The risks should be clearly explained in the consent form however; they will vary from study to study. You should understand what risks are anticipated in the particular study you are considering and remember that there can always be unanticipated risks for research subjects.

If I am injured during the study is compensation available to pay for my treatment?

Will there be any follow-up treatment after the study is over?

Will I be able to continue receiving the study drug or device when the study is over?

Who should I contact if I have a side effect and/or question?

What alternatives are there to being in the study?

What will I benefit form for being a participant in the study?

Sometimes the person (subject) who joins a research study will benefit directly, and their disease or problem will be helped. However, the possibility of receiving benefit varies from study to study, just like the risks. It is important to remember that the main goal of research is to collect information that may help future patients, not the subject participating in the research study. You should always ask questions and keep asking until you understand how the research study is different from the treatment you would get outside of the research study.

What are the costs to me and/or my insurance company?

Please keep in mind, you may be expected to pay for some or all of the tests and procedures that will be done during the study. It is different in each study. Sometimes everything is paid for in a research study, and sometimes you or your insurance will be responsible for all of the costs. Also, be aware that some insurance companies will not pay for medical care that is given as part of a research study, so you may be responsible for those costs. Find out what you or your insurance will be billed before you agree to be in a research study. You may also want to contact your insurance company, although it is sometimes difficult to get them to tell you what they will pay for.

A subject must be told about any new information learned during the study that may affect his or her willingness to continue to take part in the study. A subject may ask questions at any time throughout the study and may decide to stop taking part for any reason.

Only you can decide whether a clinical trial is right for you. Only you can balance the benefits and risks and determine which are more important to you.

Question: What is my responsibility as a participant in the study?

Answer: You will be expected to show up for all scheduled appointments, call the study personnel if you have a bad reaction, and follow the study related instructions given to you. You may also be expected to go in for many more visits than you would have with regular care. Therefore, you may have extra costs, such as parking, babysitting and time off work.

Question: What are my rights as a study participant?

Answer: You have several rights as a research subject:

You have the right to decide not to participate in the research, and there will be no penalty or loss of benefits. In fact, no one is allowed to perform research with you unless you have given your permission and signed an informed consent document (sometimes just called a "consent form").

If you decide to participate, you have the right to quit at any time. You do not give up any of your legal rights when you sign the informed consent document and join a study. Again, there will be no penalty or loss of benefits.

You have the right to be informed about the research study, without any coercion, undue influence, or pressure. Your main source of information about the research study is usually the consent form.

You have the right to ask questions about the research study.

You have the right to take plenty of time, without anyone pressuring you, to decide whether or not to join a study.

You have the right to discuss with your doctor, your family, and your friends, whether or not you should join a study.

You have the right to keep your medical information confidential.

You have the right to receive medical treatment for any injury that might happen to you on a study.

You have the right to get a copy of the consent form.

You do not waive any of your legal rights by joining a research study or signing a consent form.

Deciding to be in a research study is an important decision and requires that you understand what your expectations are. You should talk about your expectations with the study staff before you agree to be in a research study

Question: When should I contact the IRB?

Answer: If you have questions about the conduct of the study or your rights as a research participant, you should contact the IRB at the number listed in the informed consent document. If you have questions about a research related injury, contact the study doctor.

Question: What are some of the reasons others participate in research studies?

Answer: There are many reasons why a person may choose to be in a research study. If you are considering joining a research study, you should think about what your reasons and goals are for joining and discuss them with friends, family, a trusted health care provider and with the principal investigator or other study personnel. Talking with these people should help you determine if your reason(s) for joining the study agrees with what may happen as a result of your participation and the question the research is trying to answer.

The following are examples of reasons why people join research studies:

Some healthy people decide to join a study because they want to help in developing a cure for a particular disease.

Some people decide to join a research study because they have a disease or condition and they want to help find a cure.

Some people decide to join because they have a disease or condition that has not responded to any of the medications available to treat the condition.

Some people decide to join because they have a very advanced stage of disease and no treatment option is available.

Some people decide to join because they have a disease or condition and they have had bad reactions to the available treatments and they are looking for something with fewer side effects.

Some people decide to join a study because they want the money that is paid to subjects.

Whatever your reason, you need to know that there can never be any guarantee given to you that the research drug, device or procedure will work for you or will ever work well enough to be approved for general use. A doctor may tell you about a research study because he or she thinks you may meet the requirements for enrolling. Just because a research study is suggested to you does not mean that you have to join it.

Question: Where can I find out more about clinical research studies?

More information about clinical research studies is available form your doctor. E&I has also provided some useful links to to other internet sites.